United States

US Approves World's First Vaccine For Declining Honey Bees (bbc.com) 100

The US has approved use of the world's first vaccine for honey bees. The BBC reports: The US Department of Agriculture (USDA) approved a conditional license for the vaccine this week, according to the biotech firm behind its development. It was engineered to prevent fatalities from American foulbrood disease, a bacterial condition known to weaken colonies by attacking bee larvae. [...] American foulbrood disease poses a challenge for beekeepers as it is highly contagious and has no cure. The only treatment method requires burning the colony of infected bees along with the hives and equipment and treating nearby colonies with antibiotics.

The new vaccine contains an inactive version of the bacteria that causes American foulbrood disease, Paenibacillus larvae, according to Dalan Animal health. The bacteria are incorporated into royal jelly feed given by worker bees to the queen bee, which then ingests the feed and keeps some of the vaccine in her ovaries, according to the biotech firm, which specializes in insect health and immunology. It says this gives bee larvae immunity to the disease as they hatch and reduces death from the illness. [...] Dalan plans to distribute the vaccine "on a limited basis" to commercial beekeepers and said the product would probably be available for purchase in the US this year.

Medicine

Teenager's Incurable Cancer Cleared With Revolutionary DNA-Editing Technique (bbc.com) 78

"A teenage girl's incurable cancer has been cleared from her body," reports the BBC, "in the first use of a revolutionary new type of medicine...." Doctors at Great Ormond Street Hospital used "base editing" to perform a feat of biological engineering to build her a new living drug. Six months later the cancer is undetectable, but Alyssa is still being monitored in case it comes back.

Alyssa, who is 13 and from Leicester, was diagnosed with T-cell acute lymphoblastic leukaemia in May last year.... Her cancer was aggressive. Chemotherapy, and then a bone-marrow transplant, were unable to rid it from her body.... The team at Great Ormond Street used a technology called base editing, which was invented only six years ago [which] allows scientists to zoom to a precise part of the genetic code and then alter the molecular structure of just one base, converting it into another and changing the genetic instructions. The large team of doctors and scientists used this tool to engineer a new type of T-cell that was capable of hunting down and killing Alyssa's cancerous T-cells....

After a month, Alyssa was in remission and was given a second bone-marrow transplant to regrow her immune system.... Alyssa is just the first of 10 people to be given the drug as part of a clinical trial.

Her mother said that a year ago she'd been dreading Christmas, "thinking this is our last with her". But it wasn't.

And the BBC adds that applying the technology to cancer "only scratches the surface of what base editing could achieve.... There are already trials of base editing under way in sickle-cell disease, as well as high cholesterol that runs in families and the blood disorder beta-thalassemia."
Earth

'The 10 Most Promising Breakthrough Innovations of 2022' (theatlantic.com) 60

This week the Atlantic published its list of "the 10 Most Promising Breakthrough Innovations of 2022."

"We didn't just get one 'unheard-of' cancer breakthrough; we got several in one year...." Is death reversible? It was this year for several pigs (or, at least, for their organs). By pumping an experimental substance into the veins and arteries of animals that had been lying deceased for an hour, Yale researchers got their hearts to start beating again. The technology is "very far away from use in humans," Stephen Latham, a bioethicist at Yale University, told The New York Times. In the short term, scientists said, they hope that their research could help doctors preserve the organs of the recently deceased for use in transplants. But the longer-term implications of the experiment can't be ignored: If we have the power to reanimate the heart or other organs of the recently deceased, at what point might we be able to reverse sudden deaths? Could we revive soldiers who bleed out on the battlefield? Could we stock hospitals and nursing homes with buckets of the stuff to resuscitate patients? Should every future American household keep some on hand in the event of a terrible accident?

These questions thrust us into the ethical realm and invoke spooky references to "The Monkey's Paw," Pet Sematary, and any number of stories about the dark side of trying to design an escape hatch from mortality. Perhaps, as this technology improves, that debate is on its way. But for millions of people who have lost loved ones to, say, a sudden heart attack or stroke, it's not remotely dystopian to imagine an injection that could reverse tragedies long considered irreversible....

The Power to Synthesize Life (Kind Of)
This summer, scientists grew an embryo in a lab without the use of sperm, or eggs, or a womb. It happened to be that of a mouse. But the species is of secondary importance.... Some scientists I consulted for this project said that the results, which were published this year in the science journal Cell, were the most important scientific breakthrough of 2022.

Scientists are not close to turning stem cells into human babies that make their first gasping cries in antiseptic laboratories. But this work does suggest a major leap forward in our ability to grow synthetic organs and more closely research the relationship between embryonic mutations and developmental diseases. As Paul Tesar, a developmental biologist at Case Western Reserve University School of Medicine, told Stat, "As soon as the science starts to move into a place where it's feasible to go from a stem cell population in a Petri dish all the way through to organ development, it's a pretty wild and remarkable time."

The article also notes that NuScale's small nuclear reactors received approval from the U.S. Nuclear Regulatory Commission, and "could be running by the end of the decade." Meanwhile, the start-up Quaise is working on drilling technology "that can vaporize granite with a highly concentrated beam of radio-frequency power. If such a technology became widely available, deep drilling would be commonplace and geothermal energy would be accessible on just about any patch of land. It would be as though humankind conceived of a magic wand that, waved across the Earth, makes any square mile as energy-rich as an oil-gushing stretch of Texas or Saudi Arabia."

The article also suggests one more possibility for the future. "Decades from now, millions of people may actually prefer the consistency and taste of meat that didn't come from an animal, because they'll know what they're buying when a cultivated rib eye is as consistent as an electrical gadget."
Biotech

Former Theranos COO Sunny Balwani Sentenced To Nearly 13 Years In Prison (cnbc.com) 73

An anonymous reader quotes a report from CNBC: Former Theranos chief operating officer and president Ramesh "Sunny" Balwani was sentenced to nearly 13 years in prison Wednesday for fraud, after the unraveling of the blood-testing juggernaut prompted criminal charges in California federal court against both Balwani and Theranos founder Elizabeth Holmes, who on Nov. 18 was sentenced to more than 11 years in prison.

During the sentencing hearing, attorneys for Balwani attempted to pin the blame on Holmes, telling U.S. District Court Judge Edward J. Davila that "decisions were made by Elizabeth Holmes." Davila had set a sentencing range of 11 years plus 3 months to 14 years, but prosecutors today sought a 15-year sentence given his "significant" oversight role at Theranos' lab business. The final guideline sentence was 155 months, plus three years of probation. Davila set a Mar. 15, 2023, surrender date. [...] Balwani's sentencing in federal court marks the end of the Theranos saga, which enthralled the public and prompted documentary films and novel treatments.

Education

Stanford Investigates Its President Over Allegations of Past Research Misconduct (msn.com) 22

Marc Tessier-Lavigne is president of Stanford University. He's also "the subject of a university investigation," reports SFGate, "following a report from the school's newspaper, the Stanford Daily, that he committed scientific research misconduct" in papers he co-authored years ago which may contain altered images.

More from the Washington Post: The university launched the inquiry after the Stanford Daily, a campus newspaper, reported that a well-known research journal was looking into concerns raised about a 2008 paper co-authored by Marc Tessier-Lavigne. The Daily reported that in addition to the paper in the European Molecular Biology Organization Journal, there were questions about other published research.

Some of those complaints were first made many years ago, and Tessier-Lavigne had tried to correct papers at one journal in 2015, according to its editor.... Tessier-Lavigne said in a statement that he supports the inquiry. "Scientific integrity is of the utmost importance both to the university and to me personally," Tessier-Lavigne said. "I support this process and will fully cooperate with it, and I appreciate the oversight by the Board of Trustees...."

Elisabeth Bik, who had been a staff scientist at Stanford doing postdoctoral microbiology research until 2016 and is now a well-known research integrity consultant who specializes in photographic images, said she heard about the questions about some papers of which Tessier-Lavigne is one of the authors a few years after they were first raised, and identified additional possible problems.

Most appeared to be minor concerns, and they could have been honest mistakes, she said. This week, Bik said, she spotted a more troubling instance in a paper from 1999 with multiple authors where it appeared photos had been altered, which she said was suggestive of copying and pasting.

The Los Angeles Times describes Tessier-Lavigne as "a neuroscientist and biotech entrepreneur widely known for his Alzheimer's research" who "has authored or co-authored about 300 scientific papers."
AI

Will Neural Sensors Lead to Workplace Brain Scanning? (ieee.org) 68

"Get ready: Neurotechnology is coming to the workplace," claims IEEE Spectrum: Neural sensors are now reliable and affordable enough to support commercial pilot projects that extract productivity-enhancing data from workers' brains.

These projects aren't confined to specialized workplaces; they're also happening in offices, factories, farms, and airports. The companies and people behind these neurotech devices are certain that they will improve our lives. But there are serious questions about whether work should be organized around certain functions of the brain, rather than the person as a whole.

To be clear, the kind of neurotech that's currently available is nowhere close to reading minds. Sensors detect electrical activity across different areas of the brain, and the patterns in that activity can be broadly correlated with different feelings or physiological responses, such as stress, focus, or a reaction to external stimuli. These data can be exploited to make workers more efficient — and, proponents of the technology say, to make them happier. Two of the most interesting innovators in this field are the Israel-based startup InnerEye, which aims to give workers superhuman abilities, and Emotiv, a Silicon Valley neurotech company that's bringing a brain-tracking wearable to office workers, including those working remotely....

EEG has recently broken out of clinics and labs and has entered the consumer marketplace. This move has been driven by a new class of "dry" electrodes that can operate without conductive gel, a substantial reduction in the number of electrodes necessary to collect useful data, and advances in artificial intelligence that make it far easier to interpret the data. Some EEG headsets are even available directly to consumers for a few hundred dollars.

Biotech

FDA Approves a Treatment that Delays Onset of Type 1 Diabetes (go.com) 33

For the first time, America's Food and Drug Administration has "approved a treatment that can delay the onset of Type 1 diabetes," reports ABC News: Teplizumab, a monoclonal antibody that will be marketed under the brand name Tzield from pharmaceutical companies ProventionBio and Sanofi, is administered through intravenous infusion. The injection was shown in clinical trials to delay onset of insulin-dependent Type 1 diabetes for patients with autoantibody markers of early risk by over two years, with hopes for some that it can delay onset even longer.... Tzield was approved to delay the onset of stage 3 Type 1 diabetes in adults and children ages 8 and up who currently have stage 2 Type 1 diabetes.

The medication is thought to slow down the body's attack on its own insulin-producing cells and thus give people more time before they become dependent on pharmaceutical insulin. Tzield is not suitable for people with insulin-dependent Type 1 diabetes, people who are pre-Type 2 diabetics or those with type 2 diabetes. "This approval is a watershed moment for the treatment and prevention of type 1 diabetes," said Dr. Mark S. Anderson, director of the University of California San Francisco Diabetes Center. "Until now, the only real therapy for patients has been a lifetime of insulin replacement. This new therapy targets and helps to halt the autoimmune process that leads to the loss of insulin...."

Studies have shown that 75% of people with these diagnostic markers usually become insulin-dependent within five years and nearly 100% at some point in their lifetime.

ABC News also shares this quote from Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research. "The drug's potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."
Biotech

Former Theranos CEO Elizabeth Holmes Sentenced To More Than 11 Years In Prison (cnbc.com) 158

Theranos founder Elizabeth Holmes was sentenced Friday in a federal court to 135 months, more than 11 years in prison following her conviction on four counts of criminal fraud. The court found she deceived investors, including News Corp.'s Rupert Murdoch and a host of other luminaries, about the efficacy of Theranos' blood-testing technology. CNBC reports: Holmes cried while speaking to the court ahead of her sentencing. "I loved Theranos. It was my life's work," Holmes said. "My team meant the world to me. I am devastated by my failings. I'm so so sorry. I gave everything I had to build my company." Her defense team argued she should face a maximum sentence of 18 months, according to court filings.

The Wall Street Journal first broke the story of how Theranos' blood-testing technology was struggling to meet expectations in 2015. Whistleblowers and other witnesses came forth to provide detailed accounts of how Holmes and former operating chief Ramesh "Sunny" Balwani deceived patients, partners, investors and employees about the company's progress and the capabilities of its technology. "Thank you for having me. Thank you for the courtesy and respect you have shown me," she said Friday. "I have felt deep pain for what people went through because I failed them. To investors, patients, I am sorry." Prosecutors sought a 15 year sentence for the pregnant 38-year-old former billionaire and Silicon Valley celebrity.
Developing...
The Courts

Prosecutors Seek 15-Year Prison Sentence for Theranos' Elizabeth Homes, $800M Restitution (theguardian.com) 112

"Federal prosecutors are asking a judge to sentence Elizabeth Holmes to 15 years in prison," reports the Guardian, "and require the Theranos founder to pay $800m in restitution, according to court documents filed on Friday." A jury found Holmes guilty in January of four counts of investor fraud and conspiracy. Her sentencing is scheduled for 18 November, and she faces a maximum 20 years in prison. Prosecutors argued that "considering the extensiveness of Holmes's fraud", their recommended sentencing would "reflect the seriousness of the offenses, provide for just punishment for the offenses, and deter Holmes and others".

Holmes's lawyer argued in documents filed on Thursday that the ex-Theranos boss should not be sentenced to prison at all and, at most, should receive 18 months of house arrest. The court filings argued that Holmes had been made a "caricature to be mocked and vilified" by the media over the years, though she is a caring mother and friend.

"Ms Holmes is no danger to the public," Holmes's lawyer said in the court documents. "She has no criminal history, has a perfect pretrial services compliance record, and is described by the people who know her repeatedly as a gentle and loving person who tries to do the right thing."

Biotech

Police Use DNA Phenotyping To Limit Pool of Suspects To 15,000 (vice.com) 50

An anonymous reader quotes a report from Motherboard: The Queensland, Australia police have used DNA phenotyping for the first time ever in hopes of leading to a breakthrough for a 1982 murder. The department partnered with a U.S.-based company called Parabon NanoLabs to create a profile image of the murder suspect, a Caucasian man with long blonde hair. Police claim that this image was generated using blood samples found at the scene of the murder of a man from 40 years ago; according to the Australian Broadcasting Corporation this is the first time "investigative genetic genealogy" has been used in Queensland.

This image does not factor in any environmental characteristics, such as tattoos, facial hair, and scars, and cannot determine the age or body mass of the suspect. However, Queensland investigators have published the image online and are offering a $500,000 reward and indemnity from prosecution to anyone who might have information about the suspect. The image is a vague rendering of a man that does not provide any more information than the sketch that the department already has of the suspect. This further perpetuates the hyper-surveillance of any man who resembles the image. Parabon NanoLabs has already been criticized by criminal justice and privacy experts for disseminating images that implicate too broad a pool of suspects.

The Queensland police department said that the DNA sample from the case generated a genealogy tree of "15,000 'linked' individuals" and they have not been able to find a close match yet. Instead of facing the possibility that DNA phenotyping may not be an effective tool for narrowing down a suspect, the police department's strategy is to ask the public for their DNA samples. Criminologist Xanthe Mallett said in a press release that to help police find a match, people can "opt-in" to share their own DNA samples with investigators through DNA services such as Family Tree and GEDMatch.
"Many members of the public that see this generated image will be unaware that it's a digital approximation, that age, weight, hairstyle, and face shape may be very different, and that accuracy of skin/hair/eye color is approximate," said Callie Schroeder, the Global Privacy Counsel at the Electronic Privacy Information Center.
Medicine

Vaccines to Treat Cancer Possible by 2030, Say BioNTech Founders (bbc.com) 150

Ugur Sahin and and Özlem Türeci. The BBC calls them "the husband and wife team behind one of the most successful Covid vaccines" — the couple who co-founded the German biotech company BioNTech in 2008, "exploring new technology involving messenger RNA to treat cancer."

And though they partnered with Pfizer to ues the same approach for their Covid vaccine, "Now the doctors are hopeful it could lead to new treatments for melanoma, bowel cancer and other tumour types." BioNTech has several trials in progress, including one where patients are given a personalised vaccine, to prompt their immune system to attack their disease. The mRNA technology being used works by sending an instruction or blueprint to cells to produce an antigen or protein. In Covid this antigen is part of the spike protein of the virus. In cancer it would be a marker on the surface of tumour cells. This teaches the immune system to recognise and target affected cells for destruction.

Speaking on the BBC's Sunday with Laura Kuenssberg, Prof Tureci said: "mRNA acts as a blueprint and allows you to tell the body to produce the drug or the vaccine... and when you use mRNA as a vaccine, the mRNA is a blueprint for the 'wanted poster' of the enemy — in this case cancer antigens which distinguish cancer cells from normal cells."

Harnessing the power of mRNA to produce vaccines was unproven until Covid. But the success of mRNA vaccines in the pandemic has encouraged scientists working with the technology in cancer.

The Guardian notes that the couple said cancer-targetting vaccines could be available "before 2030", though Özlem Türeci warns that "As scientists we are always hesitant to say we will have a cure for cancer. We have a number of breakthroughs and we will continue to work on them." BioNTech was working on mRNA cancer vaccines before the pandemic struck but the firm pivoted to produce Covid vaccines in the face of the global emergency. The firm now has several cancer vaccines in clinical trials.
Biotech

Rats With (Part) Human Brains (statnews.com) 54

Long-time Slashdot reader mspohr shares a report from the Boston Globe's health-news site STAT: The scientist flicked on a laser, filling the rat's brain with blue light. The rodent, true to its past two weeks of training, scampered across its glass box to a tiny spout, where it was duly rewarded with a drink of water. From the outside, this would appear to be a pretty run-of-the-mill neuroscience experiment, except for the fact that the neurons directing the rat to its thirst-quenching reward didn't contain any rat DNA. Instead, they came from a human "mini-brain" — a ball of human tissue called an organoid — that researchers at Stanford University School of Medicine had grown in a lab and implanted in the rodent's cortex months before.

The experiment — part of a study published Wednesday in Nature — is the first describing human neurons influencing another species' behavior. The study also showed that signals could go the other way; tendrils of human neurons mingled with the rodent brain cells and fired in response to air rustling the rats' whiskers.

The advance opens the door to using such human-rodent chimeras to better understand how the human brain develops and what goes wrong in neurological and psychiatric conditions such as schizophrenia, autism, and epilepsy. When the Stanford scientists implanted organoids grown from the cells of patients with a severe genetic brain disorder, they could watch the neurons develop abnormally with unprecedented clarity.

"This paper really pushes the envelope," said neuroscientist Tomasz Nowakowski, of the University of California, San Francisco, who uses brain organoids in his research on neurodevelopmental disorders but was not involved in the new work. "The field is desperate for more experimental models. And what's really important about this study is it demonstrates that brain organoids can complete their maturation trajectory when transplanted. So it really expands our toolkit for asking more nuanced questions about how genetic mutations lead to behavioral disorders."

It's an example of how stem cells have revolutionized brain research. By "doing their experiments in very young rats whose cortexes are not yet saturated with synapses," the article points out, the researchers "found that the human neurons easily integrated into the animals' rapidly expanding circuitry, which provided them with the stimulation they needed to push past previous developmental barriers."
Biotech

The Era of Fast, Cheap Genome Sequencing Is Here (wired.com) 32

Emily Mullin writes via Wired: The human genome is made of more than 6 billion letters, and each person has a unique configuration of As, Cs, Gs, and Ts -- the molecular building blocks that make up DNA. Determining the sequence of all those letters used to take vast amounts of money, time, and effort. The Human Genome Project took 13 years and thousands of researchers. The final cost: $2.7 billion. That 1990 project kicked off the age of genomics, helping scientists unravel genetic drivers of cancer and many inherited diseases while spurring the development of at-home DNA tests, among other advances. Next, researchers started sequencing more genomes: from animals, plants, bacteria, and viruses. Ten years ago, it cost about $10,000 for researchers to sequence a human genome. A few years ago, that fell to $1,000. Today, it's about $600.

Now, sequencing is about to get even cheaper. At an industry event in San Diego today, genomics behemoth Illumina unveiled what it calls its fastest, most cost-efficient sequencing machines yet, the NovaSeq X series. The company, which controls around 80 percent of the DNA sequencing market globally, believes its new technology will slash the cost to just $200 per human genome while providing a readout at twice the speed. Francis deSouza, Illumina's CEO, says the more powerful model will be able to sequence 20,000 genomes per year; its current machines can do about 7,500. Illumina will start selling the new machines today and ship them next year.

Illumina's sequencers use a method called "sequencing by synthesis" to decipher DNA. This process first requires that DNA strands, which are usually in double-helix form, be split into single strands. The DNA is then broken into short fragments that are spread onto a flow cell -- a glass surface about the size of a smartphone. When a flow cell is loaded into the sequencer, the machine attaches color-coded fluorescent tags to each base: A, C, G, and T. For instance, blue might correspond to the letter A. Each of the DNA fragments gets copied one base at a time, and a matching strand of DNA is gradually made, or synthesized. A laser scans the bases one by one while a camera records the color coding for each letter. The process is repeated until every fragment is sequenced. For its latest machines, Illumina invented denser flow cells to increase data yield and new chemical reagents, which enable faster reads of bases. "The molecules in that sequencing chemistry are much stronger. They can resist heat, they can resist water, and because they're so much tougher, we can subject them to more laser power and can scan them faster. That's the heart of the engine that allows us to get so much more data faster and at lower costs," says Alex Aravanis, Illumina's chief technology officer.
Illumina's new system comes at a steep cost of around $1 million, which makes them more difficult for smaller labs and hospitals to acquire. They also often require experts to run the machines and process the data.

That said, "Illumina's sequencers are completely automated and produce a report comparing each sample against a reference genome," reports Wired. "Aravanis says this automation could democratize sequencing, so that facilities without large teams of scientists and engineers can run the machines with few resources."
Biotech

Is Plant-Based Meat Fizzling In the US? (theguardian.com) 282

Citing McDonald's shelved meat-free burger trial and a 70% dip in Beyond Meat's stock, The Guardian suggests plant-based meats may not interest Americans as much as investors thought. From the report: Getting meat eaters in the US to adopt plant-based alternatives has proven a challenge. Beyond Meat, which produces a variety of plant-based products, including imitations of ground beef, burgers, sausages, meatballs and jerky, has had a rough 12 months, with its stock dipping nearly 70%. Multiple chains that partnered with the company, including McDonald's, have quietly ended trial launches. In August, the company laid off 4% of its workforce after a slowdown in sales growth. Last week, its chief operating officer was reportedly arrested for biting another man on the nose during a road rage confrontation. It's a dramatic reversal of fortune. Just two years ago, Beyond Meat, its competitor Impossible Foods and the plant-based meat industry at large seemed poised to start a food revolution.

For a time, Wall Street went vegetarian. In 2019 Beyond Meat was valued at over $10 billion, more than Macy's or Xerox. The most bullish investors believed that plant-based meat would make up 15% of all meat sales by 2030. But the reality of Americans' interest in plant-based meat has proven more complicated than investors thought, and the adoption of meat alternatives has been slower than what was once hoped. Today Beyond Meat is valued at just over $900 million. The sobering story is similar to those experienced by many new ventures that see exhilarating hype after a flood of Silicon Valley venture capital cash, fueled by excitement about innovation. Bill Gates backed Beyond Meat, and a number of venture capital firms that typically invest in tech startups funneled money to startups making plant-based meat. Even the meat industry's biggest players have, ironically, invested in companies coming up with plant-based meat.
While eating plant-based meat (or no meat at all) has been shown to be the most effective thing individual consumers can do to fight climate change, "consumers seem hesitant to adapt their behavior when the environment -- not their health or wallets -- is the sole beneficiary," reports The Guardian. "Despite the increasing alarm over climate change, the number of Americans who are vegetarian or vegan has remained relatively stable over the last 20 years."

"Even when participants in a study conducted at Purdue University in Indiana were given information about the carbon footprint of meat production, participants were more likely to go with regular meat over a plant-based alternative."
Biotech

Crispr Gene-Editing Drugs Show Promise In Preliminary Study 30

Intellia Therapeutics reported encouraging early-stage study results for its Crispr gene-editing treatments, the latest sign that the pathbreaking technology could result in commercially available drugs in the coming years. The Wall Street Journal reports: Intellia said Friday that one of its treatments, code-named NTLA-2002, significantly reduced levels of a protein that causes periodic attacks of swelling in six patients with a rare genetic disease called hereditary angioedema, or HAE. In a separate study building on previously released trial data, Intellia's treatment NTLA-2001 reduced a disease-causing protein by more than 90% in 12 people with transthyretin-mediated amyloidosis cardiomyopathy, or ATTR-CM, a genetic disease that can lead to heart failure.

Despite the positive results, questions remain about whether therapies based on Crispr will work safely and effectively, analysts said. Intellia's latest studies involved a small number of patients, and were disclosed in news releases and haven't been published in a peer-reviewed journal. The NTLA-2002 study results were presented at the Bradykinin Symposium in Berlin, a medical meeting focused on angioedema. The data came from small, so-called Phase 1 studies conducted in New Zealand and the U.K. that didn't include control groups. Results from such early studies can be unreliable predictors of a drug's safety and effectiveness once the compound is tested in larger numbers of patients. The findings, nevertheless, add to preliminary but promising evidence of the potential for drugs based on the gene-editing technology. Last year, Intellia said that NTLA-2001 reduced the disease-causing protein involved in ATTR patients.
Biotech

Woman Whose Rape Kit DNA Led To Her Arrest Sues San Francisco (apnews.com) 188

Bruce66423 shares a report from the Associated Press: A rape victim whose DNA from her sexual assault case was used by San Francisco police to arrest her in an unrelated property crime on Monday filed a lawsuit against the city. During a search of a San Francisco Police Department crime lab database, the woman's DNA was tied to a burglary in late 2021. Her DNA had been collected and stored in the system as part of a 2016 domestic violence and sexual assault case, then-District Attorney Chesa Boudin said in February in a shocking revelation that raised privacy concerns. "This is government overreach of the highest order, using the most unique and personal thing we have -- our genetic code -- without our knowledge to try and connect us to crime," the woman's attorney, Adante Pointer, said in a statement.

The revelation prompted a national outcry from advocates, law enforcement, legal experts and lawmakers. Advocates said the practice could affect victims' willingness to come forward to law enforcement authorities. Federal law already prohibits the inclusion of victims' DNA in the national Combined DNA Index System. There is no corresponding law in California to prohibit local law enforcement databases from retaining victims' profiles and searching them years later for entirely different purposes.

Boudin said the report was found among hundreds of pages of evidence against a woman who had been recently charged with a felony property crime. After learning the source of the DNA evidence, Boudin dropped the felony property crime charges against the woman. The police department's crime lab stopped the practice shortly after receiving a complaint from the district attorney's office and formally changed its operating procedure to prevent the misuse of DNA collected from sexual assault victims, Police Chief Bill Scott said. Scott said at a police commission meeting in March that he had discovered 17 crime victim profiles, 11 of them from rape kits, that were matched as potential suspects using a crime victims database during unrelated investigations. Scott said he believes the only person arrested was the woman who filed the lawsuit Monday.

The Courts

Theranos Founder Elizabeth Holmes Requests a New Trial (gizmodo.com) 96

Elizabeth Holmes -- the founder of blood testing startup Theranos and the poster child for misleading investors, media, and innocent people looking for medical care through a web of deceit -- wants a do-over. She is requesting a new trial, according to a document filed Tuesday in the Southern District Court of California. Gizmodo reports: The motion for a new trial, authored by Holmes' attorneys, hinges on "newly discovered evidence," specifically: the alleged testimony regrets of Adam Rosendorff. Rosendorff was a lab director at Theranos and later, testified as a key witness in the case against Holmes and her ex-boyfriend/partner in crime Ramesh "Sunny" Balwani. His original testimony lasted multiple days and emphasized the pressure that Theranos employees were under to demonstrate the faulty diagnostic technology worked, even when it didn't.

"I felt that it was a question on my integrity as a physician not to remain there and to continue to bolster results I essentially didn't have faith in," Rosendorff said while on the witness stand in 2021, according to CNBC. "I came to understand that management was not sincere in diverting resources to solve issues." Now, Holmes and her lawyers are claiming that Rosendorff left a voicemail and then showed up at Holmes' residence on August 8 in a desperate bid to communicate that he "felt he had done something wrong, apparently in connection with Ms. Holmes' trial." The motion, supposedly paraphrasing Rosendorff, says that the former Theranos employee stated, "the government made things seem worse than they were."

In the document, Holmes' legal team wrote, "Under any interpretation of his statements, the statements warrant a new trial under Rule 33. But, at a minimum, and to the extent the Court has any doubt about whether a new trial is required, the Court should order an evidentiary hearing and permit Ms. Holmes to subpoena Dr. Rosendorff to testify about his concerns."
Holmes was found guilty in January on four of 11 charges defrauding the company's investors and patients. She was found not guilty on four counts.

In July, Balwani was found guilty of 12 counts of conspiracy and fraud against certain investors and patients.
Biotech

Judge Declines To Overturn Elizabeth Holmes Guilty Verdict (politico.com) 56

A federal judge on Thursday tentatively declined to overturn the jury conviction of disgraced Theranos CEO Elizabeth Holmes on four felony counts of fraud and conspiracy. That leaves the former Silicon Valley star a step closer to serving prison time. Politico reports: U.S. District Judge Edward Davila won't make that decision final until Oct. 17, when he is scheduled to sentence Holmes in the same San Jose, California, courtroom where a jury found her guilty of duping investors in her much-hyped blood-testing startup. Holmes, 38, faces up to 20 years in prison and a $250,000 fine, plus restitution, for lying to investors about a Theranos technology she hailed as a revolution in healthcare but which in practice produced dangerously inaccurate results.
Medicine

Major Test of First Possible Lyme Vaccine In 20 Years Begins (apnews.com) 58

An anonymous reader quotes a report from The Associated Press: Researchers are seeking thousands of volunteers in the U.S. and Europe to test the first potential vaccine against Lyme disease in 20 years -- in hopes of better fighting the tick-borne threat. Lyme is a growing problem, with cases rising and warming weather helping ticks expand their habitat. While a vaccine for dogs has long been available, the only Lyme vaccine for humans was pulled off the U.S. market in 2002 from lack of demand, leaving people to rely on bug spray and tick checks. Now Pfizer and French biotech Valneva are aiming to avoid previous pitfalls in developing a new vaccine to protect both adults and kids as young as 5 from the most common Lyme strains on two continents.

Most vaccines against other diseases work after people are exposed to a germ. The Lyme vaccine offers a different strategy -- working a step earlier to block a tick bite from transmitting the infection, said Dr. Gary Wormser, a Lyme expert at New York Medical College who isn't involved with the new research. How? It targets an "outer surface protein" of the Lyme bacterium called OspA that's present in the tick's gut. It's estimated a tick must feed on someone for about 36 hours before the bacteria spreads to its victim. That delay gives time for antibodies the tick ingests from a vaccinated person's blood to attack the germs right at the source.

In small, early-stage studies, Pfizer and Valneva reported no safety problems and a good immune response. The newest study will test if the vaccine, called VLA15, really protects and is safe. The companies aim to recruit at least 6,000 people in Lyme-prone areas including the Northeast U.S. plus Finland, Germany, the Netherlands, Poland and Sweden. They'll receive three shots, either the vaccine or a placebo, between now and next spring's tick season. A year later, they'll get a single booster dose.

Biotech

MIT Engineers Develop Stickers That Can See Inside the Body (mit.edu) 22

Live and high-resolution images of a patient's internal organs are already possible with ultrasound imaging technology. But currently the technology "requires bulky and specialized equipment available only in hospitals and doctor's offices," explains an annoncement from MIT.

Now a new design by MIT engineers "might make the technology as wearable and accessible as buying Band-Aids at the pharmacy." In a paper appearing today in Science, the engineers present the design for a new ultrasound sticker — a stamp-sized device that sticks to skin and can provide continuous ultrasound imaging of internal organs for 48 hours.

The researchers applied the stickers to volunteers and showed the devices produced live, high-resolution images of major blood vessels and deeper organs such as the heart, lungs, and stomach. The stickers maintained a strong adhesion and captured changes in underlying organs as volunteers performed various activities, including sitting, standing, jogging, and biking....

From the stickers' images, the team was able to observe the changing diameter of major blood vessels when seated versus standing. The stickers also captured details of deeper organs, such as how the heart changes shape as it exerts during exercise. The researchers were also able to watch the stomach distend, then shrink back as volunteers drank then later passed juice out of their system. And as some volunteers lifted weights, the team could detect bright patterns in underlying muscles, signaling temporary microdamage.

"With imaging, we might be able to capture the moment in a workout before overuse, and stop before muscles become sore," says Chen. "We do not know when that moment might be yet, but now we can provide imaging data that experts can interpret."

They're already envisioning other possibilities: If the devices can be made to operate wirelessly — a goal the team is currently working toward — the ultrasound stickers could be made into wearable imaging products that patients could take home from a doctor's office or even buy at a pharmacy. "We envision a few patches adhered to different locations on the body, and the patches would communicate with your cellphone, where AI algorithms would analyze the images on demand," says the study's senior author, Xuanhe Zhao, professor of mechanical engineering and civil and environmental engineering at MIT.

"We believe we've opened a new era of wearable imaging: With a few patches on your body, you could see your internal organs."

Slashdot Top Deals